Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
- Conditions
- Prostate Cancer
- Interventions
- Drug: Treatment with WST09 Vascular Photodynamic therapy
- Registration Number
- NCT00312442
- Lead Sponsor
- STEBA France
- Brief Summary
The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.
- Detailed Description
This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2 mg/kg), in combination with per-cutaneous interstitial illumination using laser light (wavelength at 763nm) delivered through optical fibres positioned through the perineum in the prostatic lobes.
Patients who are eligible to participate in the study must have a clinically diagnosed positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels on three consecutive occasions (at least 3 months apart) post-radiation treatment.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 16
Histologically proven localized prostate cancer after receiving external radiation therapy;
Patients unwilling or unable to give informed consent; Patients who received or are receiving chemotherapy; Patients previously treated with HIFU, cryotherapy, other salvage treatments, or with a trans-urethral resection of the prostate (TURP); Patients whose previous radiation therapy caused extensive cystitis and/or proctitis.
Patients suspected of Disseminated Intravascular Coagulation (DIC). Patients with prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, artrial fibrillation and / or sustained arrhythmia.
Patients whose cardiac status does not allow general anesthesia. Patients with history of thromboses or thrombo-embolisms. Patients with history of stroke or transient ischemic attack.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WST 09 Treatment with WST09 Vascular Photodynamic therapy Treatment with WST09-mediated VTP
- Primary Outcome Measures
Name Time Method Prostate biopsy results at Month 6 after treatment. 6 months
- Secondary Outcome Measures
Name Time Method Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP. 6 months PSA levels taken periodically for 1 year after the procedure Month 1,3,6 and 1 year Hypoperfusion according to MRI at Week 1 after the procedure. 1 week and Month 6 Calculated PSA velocity before and after WST09-mediated VTP. Month 1,3,6 and 1 year Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy Month 1,3,6 and 1 year To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population Day1,Day 7, Month1,3,6,and 12 The evaluation of safety will be based on reported adverse events, changes in vital signs and laboratory tests from the Treatment Visit until the study is completed.
Trial Locations
- Locations (1)
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada